Recall Z-0436-2022 ยท LSR Reagent, Borrelia Serological Reagent
bioMerieux, Inc.
VIDAS Lyme IgM II (LYM), REF 416436
| Date | Sep 22, 2021 |
| Status | Open, Classified |
| Reason | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test. |
| Root cause | Nonconforming Material/Component |
| Action | For products with No remaining shelf life (taking into account the revised expiration date): - Identify impacted lots - Stop using the listed impacted lots - Destroy the remaining impacted lots in your inventory For products with remaining shelf life (taking into account the revised expiration date): - Identify impacted products and lots listed - Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1 - Continue product use until the revised expiration date. Consignees are asked to distribute this |
| Quantity | Three lots |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.